India Changes Medical Device Application Processing System
On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.
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India’s Class C and D Import License Enforcement Deadline Fast-Approaching
On April 1, 2024, the Central Drugs Standard Control Organization’s (CDSCO) grace period for Non-Regulatory Class C and D medical devices in India comes to a close.
CDSCO Issues Updates to IVD Classification List in India
The Central Drugs Standard Control Organisation (CDSCO) of India issued a notice (PDF) on October 25, 2023 classifying in-vitro diagnostic (IVD) medical devices under medical device rules. The updates to IVD classification in India include intended use, associated risk, and other parameters.
Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit
On October 6, 2023, a team of enthusiastic members from the AAI (Artificial Intelligence and Innovation) group, including Ashoniya Puri, Sanjay Singh, and Rajat Budhori, had the honor of attending the prestigious 15th CII Global MedTech Summit. Hosted by the Confederation of Indian Industry (CII), one of India’s largest industry bodies, this event brought together key players in the MedTech sector, both from India and abroad. The summit revolved around the central theme, “Paving the way for a USD 50 billion MedTech Industry by 2030,” signifying a collective vision for the industry’s future growth.
India Grants Import License Grace Period for Class C/D Devices
On October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2023-DC (344), granting a grace period for Import Licenses to qualifying Non-Regulatory Class C and D medical devices.
New Plastic Waste (PWM) Rules Affect Medical Device Importers in India
India’s Pollution Control Board (CPCB) has issued an update on plastic packaging and Plastic Waste Management (PWM) requiring importers quantify the type of plastics being imported through a brief registration process.
An Introduction to GeM, India’s Online Portal for All Public Hospital Purchases
In 2016 the Indian government launched an online portal, the Government e-Marketplace (commonly referred to as GeM) under the Ministry of Commerce and Industry to provide for efficient and transparent procurement by government agencies across the country.
India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline
On October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules.
India’s CDSCO Releases Guidance for Renewing Medical Device Import Licenses
India’s CDSCO has issued important guidance on the process for medical device Import License renewal. This process is newly coming into effect, as the first round of Import Licenses issued under the new Rules will start to expire this year.
India Requires Mandatory Local BIS Certifications for Certain Medical Devices
This blog serves as an important enforcement notice for manufacturers/importers that BIS certification is required for some of the electronic components/accessories included in medical devices, including batteries, monitors, power adaptors and more.